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Prezista (darunavir) availability of 800 mg tablet strength

FDA News






 

FDA recently approved availability of an 800 mg tablet strength for Prezista (darunavir), an HIV-1 protease inhibitor (PI) indicated for the treatment of HIV-1 infection.  The Dosage and Administration section has been changed, in part, to read: Treatment-naïve adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions: 800 mg (one 800 mg tablet or two 400 mg tablets) taken with ritonavir 100 mg once daily and with food.

Prezista is a product of Janssen Pharmaceuticals, Inc.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration



 


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Information in this article was accurate in November 14, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.